Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms that Alza Corporation has filed suit for patent infringement against Impax in the United States District Court for the District of Delaware in connection with Concerta® (methylphenidate hydrochloride) extended-release 18, 27 and 36 mg tablets. The Company previously announced on November 29, 2010, confirmation of a patent suit relating to Concerta® 54 mg tablets.
Impax's generic Concerta® products are part of the Company's Strategic Alliance Agreement with Teva Pharmaceuticals. Once the ANDA is approved by FDA, Teva will commercialize the products.
Concerta® is indicated for the treatment of Attention Deficit Hyperactivity Disorder in children 6 years of age and older, adolescents, and adults up to the age of 65. According to Wolters Kluwer Health, U.S. sales of Concerta® 18, 27, 36 and 54 mg tablets were approximately $1.4 billion for the 12 months ended February 2011.